April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Randomized Controlled Trial Of A Sustained Delivery System Of 5-fluorouracil For The Treatment Of Failing Blebs
Author Affiliations & Notes
  • Arun Kumar Narayanaswamy
    Glaucoma, Singapore Eye Research Institute, Singapore, Singapore
  • Daniel H. Su
    Glaucoma, Training and Education,
    Singapore National Eye Centre, Singapore, Singapore
  • Kelvin Lee
    Glaucoma, Training and Education,
    Singapore National Eye Centre, Singapore, Singapore
  • Jocelyn Chua
    Glaucoma, Training and Education,
    Singapore National Eye Centre, Singapore, Singapore
  • Shu-Ming Chai
    Ophthalmology,
    Singapore National Eye Centre, Singapore, Singapore
  • Pui-Yi Boey
    Training and Education,
    Singapore National Eye Centre, Singapore, Singapore
  • Ce Zheng
    Glaucoma, Training and Education,
    National University of Singapore, Singapore, Singapore
  • Tin Aung
    Glaucoma, Training and Education,
    Singapore National Eye Centre, Singapore, Singapore
    National University of Singapore, Singapore, Singapore
  • Subbu Venkataramen
    School of Materials Science and Engineering, Nanyang Technological University, Singapore, Singapore
  • Tina T. Wong
    Glaucoma, Training and Education,
    Singapore National Eye Centre, Singapore, Singapore
    National University of Singapore, Singapore, Singapore
  • Footnotes
    Commercial Relationships  Arun Kumar Narayanaswamy, None; Daniel H. Su, None; Kelvin Lee, None; Jocelyn Chua, None; Shu-Ming Chai, None; Pui-Yi Boey, None; Ce Zheng, None; Tin Aung, None; Subbu Venkataramen, None; Tina T. Wong, None
  • Footnotes
    Support  National Medical Research Council, Singapore. (NMRC/TCR/002-SERI/2008) and an unrestricted grant from AMO Singapore Pte. Ltd.
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 3448. doi:https://doi.org/
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      Arun Kumar Narayanaswamy, Daniel H. Su, Kelvin Lee, Jocelyn Chua, Shu-Ming Chai, Pui-Yi Boey, Ce Zheng, Tin Aung, Subbu Venkataramen, Tina T. Wong; Randomized Controlled Trial Of A Sustained Delivery System Of 5-fluorouracil For The Treatment Of Failing Blebs. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3448. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To determine the efficacy of subconjunctival injection of hyaluronic acid (HA) -5Fluorouracil (5FU) formulation as an adjunct in reviving bleb function following needling.

Methods: : Fifty patients were enrolled in this prospective, randomized controlled trial. One eye of each patient documented to have a failed trabeculectomy and scheduled for a needling procedure was randomized to receive either needling with HA-5FU mixture or needling with subconjunctival injection of 5FU alone. The eyes were evaluated at 3 months for a comparative efficacy of procedures. The primary outcome was percentage of subjects with an intraocular pressure (IOP) below 15 mm Hg without any medications and secondary outcomes included the need for additional needling procedures and changes in bleb morphology.

Results: : Forty nine subjects (25 in HA-5FU and 24 in 5FU groups) completed 3 months follow-up. The mean number of glaucoma medications at baseline was higher in the 5-FU group (0.8 ± 1.1 [mean ± SD] versus 0.2 ± 0.6, p=0.04). An IOP below 15 mmHg without medications was reached in 48.0 % subjects in HA-5FU group and in 33.3 % subjects in 5FU group (p=0.2). At 3 months both the HA-5FU and the 5FU groups demonstrated significant decrease in IOP from baseline (HA-5FU - decrease of 5.9 mm Hg (95% Confidence Interval [CI]: 3.4 to 8.4 mm Hg; 5FU- decrease of 6.0 mm Hg (95% CI: 3.2 to 8.2; p<0.001 for both). Inter-group comparisons for IOP change from baseline was not significant (p=0.9) Repeat needling was required more frequently in the 5FU group compared to the HA-5FU group (50.0 % Vs 12.0 %; p= 0.004). There were no significant differences in bleb vascularity or morphology between the two groups.

Conclusions: : Adjunctive HA-5FU is as effective as 5FU solution in reviving bleb function. With lower frequency of repeat needlings, this formulation appears to be a safer alternative to 5FU.

Clinical Trial: : http://www.clinicaltrials.gov NCT00607685

Keywords: wound healing • conjunctiva 
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